Purpose

The purpose of this study is to assess the efficacy and safety of K-161 ophthalmic solution for the treatment of moderate to severe dry eye disease.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Be at least 18 years of age at the time of Informed Consent - Have a reported history of dry eye disease in both eyes and a history of eye drop use for dry eye symptom - Meet all other inclusion criteria outlined in the clinical study protocol

Exclusion Criteria

  • Have any clinically significant ocular condition - Have a history of corneal refractive surgery and/or any other ocular surgical procedure within 12 months - Meet any other exclusion criteria outlined in the clinical study protocol

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
K-161
K-161 Ophthalmic Solution
  • Drug: K-161
    K-161 Ophthalmic Solution
Placebo Comparator
Placebo
Vehicle Solution
  • Drug: Placebo
    Vehicle Solution

Recruiting Locations

The University of Alabama at Birmingham School of Optometry, Clinical Eye Research Center
Birmingham, Alabama 35294

More Details

Status
Recruiting
Sponsor
Kowa Research Institute, Inc.

Study Contact

Director, Clinical Operations
919-433-1600
Clinical@KowaUS.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.